Last seen: Apr 20, 2025
One consideration when it comes to the length of times associated with change orders is the regulatory body a project manager is dealing with. The FDA...
Curing patients could be a sustainable business practice, however it does not seem reasonable. With a business model that prioritizes curing patients,...
One important aspect of task scheduling that hasn't been mentioned is the important of incorporating slack when scheduling tasks. Slack is important t...
Scope management directly influences the cost and time management of a project. As the scope increases, it comes with the expense of a higher cost (us...
A project can be well-coordinated while taking account into the 10 knowledge areas is the implementation of a change control process. Managing the 10 ...
In regards to the initiation process in medical device projects, one key input is risk management and planning to mitigate risk. This input is often o...
The FDA should have some indirect impact on verification and validation tests. Ideally, these would be guidelines for companies should follow, but sho...
EEFS should be considered multiple times during the project management lifecycle. As with risk management, holding regular meetings to assess EEFS is ...
One main factor that can contribute to how a project management could set up a project organization can be based off of the overall status of the team...
Traceability and adaptability requires a systemic change control process in order to maintain efficiency. One example of this would be features embedd...
One product that comes to mind when discussing product life cycles is the stethoscope. The acoustic stethoscope has been used since at least the 1850s...
Intended use and the technological features of a device is usually the focus when determining which regulations apply to a product. Small distinctions...
Hurdles may not be the right term to use when accidently classifying a device as a Class III instead of a Class II. From a project management prospect...
Regulatory agencies should feel the need to adapt faster to keep up with the innovation happening in the medical device field. As it was mentioned, AI...
@ms3548 Underestimating regulatory requirements is indeed a common pitfall that does not get enough attention in my view. Implementing steps for early...